FDA Inspection 871589 — Carter BloodCare
The FDA completed an inspection of Carter BloodCare on March 17, 2014 in Woodway, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 17, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Woodway, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 41 | 21 CFR 606.40(a)(1) | Provide space for examination |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9052 | 21 CFR 600.11(b) | Equipment |
| 91 | 21 CFR 606.100(b)(12) | Criteria for suitability of reissue of returned blood |
| 98 | 21 CFR 606.100(c) | Thorough investigations |